Attention Deficit Disorder With HyperactivityNCT03595826
Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD)
A study testing Neurostimulant pharmaceutical drugs in people with Attention Deficit Disorder With Hyperactivity and Developmental Coordination Disorder, run by University of KwaZulu at 1 site in South Africa.
Trial summary
This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD. It further aims to design an exercise intervention, to be utilised in the management of the symptoms of both conditions. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Developmental Coordination Disorder
- What is being tested?
- Neurostimulant pharmaceutical drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 May 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8 to 9, diagnosed with ADHD, in remedial unit or LSEN class, in mainstream school in Durban Kzn SA.
Who cannot join
- Any child having an obvious physical disability, neurological condition, musculoskeletal condition, psychiatric disorder or genetic disorder.
- Any child below age 8 and above age 9.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Therapy on the Co-Morbidity of Attention Deficit and Hyperactivity Disorder (ADHD) and Developmental Co-Ordination Disorder. (DCD)
This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD.
It further aims to design an exercise intervention, to be utilised in the management of the symptoms of both conditions.
Furthermore, it aims at establishing the efficacy of this exercise intervention, when compared with the current and most commonly used intervention, that is: neurostimulant drugs.
Read the detailed description
This study is an experimental design, having three phases. The study looks at children, aged 8 to 9, in remedial units or LSEN classes, in and around Durban, Kzn, SA; who have been diagnosed with ADHD/ADD.
Phase 1: Teachers of the children identified with ADHD/ADD, will be asked to complete a modified teacher Conner's rating, to confirm the diagnosis of ADHD/ADD. The parent will then be asked to complete a DCD questionnaire (DCDQ) to give the PI an idea of whether co-ordination difficulties exist. The PI will then administer a Motor Assessment Battery for Children (MABC) to confirm the diagnosis of DCD. From the scores derived from the 3 above tests, co-morbidity will be diagnosed. The prevalence figures of co-morbidity will be calculated and presented. Demographics of prevalence figures will be given: Gender, Population group, average age.
Phase 2: The exercise intervention will be designed, drawing from the literature and similar interventions already used in various publications.
This programme will be validated by experts (Physiotherapists and O.Ts from special needs schools) and when 70% consensus is reached on all aspects of the programme, the final version will be drafted.
Phase 3: The children found to have both conditions, in co-morbidity, will be assigned to one of 4 groups, according to parental choice, medical advice from paediatricians, GPs etc and an intervention a child is already on.
The four groups will be: medication, exercises, medication plus exercises and a control group. The intervention designed in phase 2 will be administered to the two groups opting for the exercise intervention, for a minimum of 8 sessions. The 3 pre intervention scores (Conner's, DCDQ and MABC) will be derived from phase 1, post intervention scores will be done 6 months after completion of the intervention, as it is stipulated by the rules of the MABC that the test may not be repeated sooner. The pre and post intervention scores will be compared to calculate improvement and average improvement within each group, will be calculated, to establish which intervention or combination of interventions, is the most effective.
- Being tested
- Neurostimulant pharmaceutical drugs
- Keywords
- ADHD/ADD DCD Exercises Neurostimulant Drugs
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulant pharmaceutical drugsDrug
Also called Exercise intervention, Neurostimulants + Exercise intervention, Control Group
The Pi will only administer the exercise intervention. This will consist of minimum of 8 sessions of group exercises, working on improving muscle tone, core stability, balance, fine and gross motor skills and visual motor integration. The pharmacological therapy will be administered and monitored by medical practitioners, as is the norm with most children diagnosed and treated for ADHD/ADD. Parents of participants will remain responsible entirely for the monitoring of the pharmacological therapy of their children.
| Study group | Role | What they receive |
|---|---|---|
| 1. Neurostimulant pharmaceutical drugs.. | Experimental | 1.Participants receiving medicinal drugs, such as methylphenidate/Ritalin, administered by a medical practitioner, in dosages prescribed by the practitioner, to suit the child. Receives: Drug: Neurostimulant pharmaceutical drugs |
| 2. Exercise Intervention | Experimental | Participants receiving a minimum of 8 sessions of exercise intervention, for the duration of an hour each session. Exercises will be to build muscle tone, improve core stability, enhance balance, improve fine and gross motor skills and visual motor integration. Receives: Drug: Neurostimulant pharmaceutical drugs |
| 3. Neurostimulants + Exercise intervention | Experimental | See Arms 1 and 2 above. Both interventions administered together: Pharmaceutical drugs plus exercise intervention Receives: Drug: Neurostimulant pharmaceutical drugs |
| 4. Control Group | Experimental | Participants will not receive any intervention during the research process. They will be given an intervention after the research is completed. Receives: Drug: Neurostimulant pharmaceutical drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.
Improvement or regression in symptoms of ADHD will be rated using the modified Conner's teacher rating scale, pre intervention and post intervention:
10 factors on inattention will be rated 0 (Not at all), 1 (Just a little), 2 (Pretty much) and 3 (Very much); 5 factors on impulsivity will be rated using the same scale as above and 5 symptoms of hyperactivity as well. Percentages will be derived from these ratings. A 70% or more indicates a positive diagnosis for inattention/impulsivity/hyperactivity.
Measured: Aproximately 6 months
Secondary outcomes (1)
Motor co-ordination will be rated, using DCD questionnaire
Improvement or regression in symptoms of co ordination, will be rated by the parent, using the Developmental Co-ordination Disorder Questionnaire, pre and post intervention: 15 statements related to co-ordination will be rated on the following scale: 1 (Not at all like child), 2 (A bit like child), 3 (Moderately like child), 4 (Quite a bit like child) and 5 (Extremely like child). The score will be totalled and scores of 55 and above mean that the child does NOT have co-ordination issues, scores below 55 indicate that the child has co-ordination issues.
Measured: Aproximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start2 May 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 3 phase quasi experimental design. Diagnosis and intervention.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pam Dawson, University of KwaZulu
- Investigators
- Pamela M Dawson, M.Physio, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595826
- Sponsor's protocol ID
- Co Morbid ADHD and DCD
- Status last verified
- Nov 2020
- First submitted
- 22 Apr 2018
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share my protocol, study design, intervention, statistical analysis and results. Pretty much the entire study, once comlpeted.
Publications
Nelson et al. (2015) DCD. Medscape: Drugs, diseases and Procedures.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Therapy on the Co-Morbidity of Attention Deficit and Hyperactivity Disorder (ADHD) and Developmental Co-Ordination Disorder. (DCD)
- ClinicalTrials.gov ID
- NCT03595826
- Acronym / sponsor ID
- Co Morbid ADHD and DCD
- Keywords
- ADHD/ADD DCD Exercises Neurostimulant Drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish and present the prevalence figures and demographics of the co-morbidity of ADHD and DCD.
It further aims to design an exercise intervention, to be utilised in the management of the symptoms of both conditions.
Furthermore, it aims at establishing the efficacy of this exercise intervention, when compared with the current and most commonly used intervention, that is: neurostimulant drugs.
Detailed description
This study is an experimental design, having three phases. The study looks at children, aged 8 to 9, in remedial units or LSEN classes, in and around Durban, Kzn, SA; who have been diagnosed with ADHD/ADD.
Phase 1: Teachers of the children identified with ADHD/ADD, will be asked to complete a modified teacher Conner's rating, to confirm the diagnosis of ADHD/ADD. The parent will then be asked to complete a DCD questionnaire (DCDQ) to give the PI an idea of whether co-ordination difficulties exist. The PI will then administer a Motor Assessment Battery for Children (MABC) to confirm the diagnosis of DCD. From the scores derived from the 3 above tests, co-morbidity will be diagnosed. The prevalence figures of co-morbidity will be calculated and presented. Demographics of prevalence figures will be given: Gender, Population group, average age.
Phase 2: The exercise intervention will be designed, drawing from the literature and similar interventions already used in various publications.
This programme will be validated by experts (Physiotherapists and O.Ts from special needs schools) and when 70% consensus is reached on all aspects of the programme, the final version will be drafted.
Phase 3: The children found to have both conditions, in co-morbidity, will be assigned to one of 4 groups, according to parental choice, medical advice from paediatricians, GPs etc and an intervention a child is already on.
The four groups will be: medication, exercises, medication plus exercises and a control group. The intervention designed in phase 2 will be administered to the two groups opting for the exercise intervention, for a minimum of 8 sessions. The 3 pre intervention scores (Conner's, DCDQ and MABC) will be derived from phase 1, post intervention scores will be done 6 months after completion of the intervention, as it is stipulated by the rules of the MABC that the test may not be repeated sooner. The pre and post intervention scores will be compared to calculate improvement and average improvement within each group, will be calculated, to establish which intervention or combination of interventions, is the most effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- 3 phase quasi experimental design. Diagnosis and intervention.
| Arm | Type | Receives |
|---|---|---|
| 1. Neurostimulant pharmaceutical drugs.. | Experimental | Drug: Neurostimulant pharmaceutical drugs1.Participants receiving medicinal drugs, such as methylphenidate/Ritalin, administered by a medical practitioner, in dosages prescribed by the practitioner, to suit the child. |
| 2. Exercise Intervention | Experimental | Drug: Neurostimulant pharmaceutical drugsParticipants receiving a minimum of 8 sessions of exercise intervention, for the duration of an hour each session. Exercises will be to build muscle tone, improve core stability, enhance balance, improve fine and gross motor skills and visual motor integration. |
| 3. Neurostimulants + Exercise intervention | Experimental | Drug: Neurostimulant pharmaceutical drugsSee Arms 1 and 2 above. Both interventions administered together: Pharmaceutical drugs plus exercise intervention |
| 4. Control Group | Experimental | Drug: Neurostimulant pharmaceutical drugsParticipants will not receive any intervention during the research process. They will be given an intervention after the research is completed. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 8 to 9, diagnosed with ADHD, in remedial unit or LSEN class, in mainstream school in Durban Kzn SA.
Key exclusion criteria (2 listed)
- Any child having an obvious physical disability, neurological condition, musculoskeletal condition, psychiatric disorder or genetic disorder.
- Any child below age 8 and above age 9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostimulant pharmaceutical drugsAlso: Exercise intervention, Neurostimulants + Exercise intervention, Control GroupThe Pi will only administer the exercise intervention. This will consist of minimum of 8 sessions of group exercises, working on improving muscle tone, core stability, balance, fine and gross motor skills and visual motor integration. The pharmacological therapy will be administered and monitored by medical practitioners, as is the norm with most children diagnosed and treated for ADHD/ADD. Parents of participants will remain responsible entirely for the monitoring of the pharmacological therapy of their children. | Drug | 1. Neurostimulant pharmaceutical drugs.., 2. Exercise Intervention, 3. Neurostimulants + Exercise intervention, 4. Control Group |
Primary outcome
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale.
Time frame: Aproximately 6 months
Improvement or regression in symptoms of ADHD will be rated using the modified Conner's teacher rating scale, pre intervention and post intervention: 10 factors on inattention will be rated 0 (Not at all), 1 (Just a little), 2 (Pretty much) and 3 (Very much); 5 factors on impulsivity will be rated using the same scale as above and 5 symptoms of hyperactivity as well. Percentages will be derived from these ratings. A 70% or more indicates a positive diagnosis for inattention/impulsivity/hyperactivity.
1 secondary outcome
Motor co-ordination will be rated, using DCD questionnaire
Time frame: Aproximately 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- BackgroundNelson et al. (2015) DCD. Medscape: Drugs, diseases and Procedures.
- Individual participant dataSharing planned: Yes. I plan to share my protocol, study design, intervention, statistical analysis and results. Pretty much the entire study, once comlpeted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela M Dawson, M.Physio principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulant pharmaceutical drugs in people with Attention Deficit Disorder With Hyperactivity and Developmental Coordination Disorder, run by University of KwaZulu at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inattention, impulsivity and hyperactivity will be rated, using Conners rating scale. (time frame: Aproximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.